Imagine re-growing fragile bones
Imagine finding a way to prevent hip fracture
Imagine finding a better cure for cancer
Localized Bone Formation
The Company has made oxysterols that stimulate bone formation. This action of oxysterols is mediated by targeting certain cells in the body called mesenchymal stem cells that can turn themselves into other types of cells such as bone, fat and cartilage cells. The oxysterols induce these mesenchymal stem cells to turn into bone forming cells, and they stop them from turning into fat cells
We have already had encouraging results that show bone formation in rat and rabbit spine fusion models. We believe that the best area to explore in humans is the use of oxysterols to stimulate the growth of new bone in the body during back surgery to fuse together vertebrae in the spine. This is a prevalent surgery for back pain and other problems with an unstable spine. Depending on the type of technique the surgeon uses he/she may need to add new bone where a person’s existing old bone has decayed. Currently the surgeon has some choices about what to do but each one has challenges. One of the main options is to use some of the person’s own bone taken from his or her hip. This makes the surgery more painful and difficult, and the healing time is quite long. Our compound would allow the surgeon to operate only on the spine, removing the need to harvest bone from the hip, and it would encourage the cells in the person’s body to grow new bone to strengthen the spine where the old bone had decayed and was lost
There are other areas of bone healing where surgeons would welcome a better solution. For example, when a person breaks a bone it sometimes does not knit back together naturally because the fracture is severe, or the person’s bones are incapable of healing because he or she is a diabetic or smoker. A surgeon repairing the fracture may currently have to graft bone from elsewhere in the body or use bone from a cadaver to stimulate bone formation and healing of the fracture. Our oxysterol compounds may induce bone growth around the fracture to knit the bones back together naturally. Additionally, trauma to the facial and head bones often result in a gap where bone is missing. Currently plastic surgeons have very limited tools to regenerate the lost bone. Our compounds may work with cells in a scaffold to regenerate bone that is needed to repair the defect. And finally, many dental patients in need of implants cannot benefit from them since they have lost too much bone in their jaw to allow for the implant to cement in there. Oxysterol compounds may stimulate bone formation and strengthen the areas where implants can be placed.
Why our Work is Important
Millions of orthopedic procedures are performed annually in the United States that involve bone grafting to stimulate bone formation. However despite the prevalence of such procedures and their value to patients, they are far from perfect. Using one’s own bone as graft material can add additional pain, recovery time, cost, complication and risk. Using bone other than one’s own, for example cadaver bone, adds further risk of rejection of the foreign matter by the body, or introduction of a disease carried by that bone.
Our oxysterol compounds, once developed, would enter the market as a substitute for currently used bone graft substitutes. There are a number of bone graft substitutes available today, but our oxysterols will be simple to produce in large quantities. And once tested and approved for use in humans, oxysterols will be free of issues experienced by a number of other bone graft substitutes such as the propensity to make bone where it is not desired, and even the potential to cause inflammation, cancer, and death.
In the area of back surgery, all of the issues with current bone grafting treatments come particularly into focus because the bones in our back, besides giving us mobility and stability, protect our spinal cord which is, after the brain, the largest and most important part of the nervous system.
Our VisionA new product that is easy to make, easy to use, and reduces time in surgery, patient recovery time, risk of infection and unwanted bone growth, and yet allows the patient to re-grow bone where needed.
Systemic Bone Formation
We expect to go on from localized bone healing to targeting oxysterols as bone-building agents for the treatment of osteoporosis.
Why our Work is Important
More than 44 million Americans have low bone mass, which means their bones, which internally look like a honeycomb, are losing the walls between each space in the honeycomb. As the spaces become bigger the bones become weaker and less dense. Bone density is often measured by a “T-score”. Bone density above minus 1 is considered healthy, between minus 1 and minus 2.5 is “low”, and below minus 2.5 means you have severe loss of bone density or osteoporosis.
Once you have Osteoporosis your bones become fragile and you have an increased risk of fracture. This can be especially serious in the hip and spine regions. One in two women and one in four men will break a bone due to osteoporosis. An estimated 12 million Americans have osteoporosis today.
According to the National Osteoporosis Foundation, the prevalence of bone density loss is going to increase significantly in the future. They estimate that by 2020, half of all Americans over age 50 (an estimated 57 million people according to the US census bureau) are expected to have low bone density or osteoporosis.
A range of factors increase risk of contracting the disease – aging, low body weight, low sex hormones, smoking, diabetes, and some medications. Women are more susceptible because they can lose up to 15% of their bone mineral density in the first 5 to 7 years after menopause, and they start out with lower peak bone mass than men.
At present there is no cure for osteoporosis. Prevention and treatment include calcium and vitamin D, exercise, and osteoporosis medications. Current medications mostly have the effect of preventing further bone density loss rather than restoring the bone that has been lost. There is only one FDA approved medication that improves bone density by stimulating bone formation but it has to be taken via daily injection under the skin and can have side effects including nausea, leg cramps, and dizziness and even cancer. And it doesn’t always work!
Our VisionA new product that is relatively easy to make, easy to take, and which re-builds bone, thus preventing, delaying, or reversing bone loss and the dangers of major bone fractures, without major side effects, would be a big step forward in management of osteoporosis.
Separate from the class of oxysterols that MAX BioPharma is developing for bone growth, the company is developing oxysterols as therapeutic agents for intervention in human cancers. We believe that specific oxysterols have the potential to inhibit the growth of cancer cells because they block processes and messages that allow for tumor cells to grow and metastasize. Among the things oxysterols do is inhibit Hedgehog pathway signaling in tumor cells, including in pancreatic and blood malignancies. When Hedgehog pathway is continuously activated in an unregulated manner, it can cause tumor formation and its inhibition has been shown to block tumor formation. If successfully developed, oxysterols would increase the range of treatment options for patients with cancer, providing a more effective therapy and hopefully with less side effects than traditional therapies.
Tumor Cell Growth
Why our Work is Important
A number of the cancers that affect humans are potentially fatal and, once detected, the chance of survival for very long is low.
An example would be pancreatic cancer. It is the fourth leading cause of cancer death in the US, and is expected to become 2nd leading cause by 2020. In 2014, an estimated 46,420 people will be diagnosed with pancreatic cancer in the US, and approximately 40,000 will die from the disease. As US population demographics change, the number of new cases of pancreatic cancer is expected to increase more than 2-fold and the number of deaths will increase 2.4-fold by the year 2030. Because the pancreas is located deep in the abdomen early detection of cancer is difficult. By the time it is detected, surgical removal of the tumor is possible in only about 15% of patients with the most common type of pancreatic cancer. Chemotherapy or chemotherapy with radiation and drug therapies are available but survival rates remain low.
Scientists at MAX BioPharma have made a number of promising oxysterols that block the growth of pancreatic cancer cells and inhibit the Hedgehog pathway in tumor cells. The company has also found effective inhibition of multiple myeloma cells when anti-cancer oxysterols are administered to them. Together with colleagues at John Hopkins Institute, the company is pursuing the therapeutic development of oxysterols for treating deadly human cancers.
Our VisionA Hedgehog pathway inhibitory drug that is relatively easy to make, has fewer side effects to current chemotherapy, and is effective at reducing or preventing tumor growth and metastasis in major types of cancer, either alone or in combination with other drugs or therapies, would be a major breakthrough in management of cancer patients.